Division of Gastroenterology, McMaster University, Hamilton Ontario, Canada.
Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA.
Endoscopy. 2015 Oct;47(10):884-90. doi: 10.1055/s-0034-1392418. Epub 2015 Jul 10.
BACKGROUND AND STUDY AIM: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi dysfunction (SOD). Here we aimed to identify predictors of the risk in this population. PATIENTS AND METHODS: The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure. RESULTS: PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval [95 %CI] 0.34 - 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % [95 %CI 6.0 % - 19.5 %]) compared with dual sphincterotomy (3/47; 6.4 % [95 %CI 0.0 % - 13.4 %]). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P < 0.02). CONCLUSION: The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored.Clinicaltrials.gov registration: NCT00688662.
背景与研究目的：内镜逆行胰胆管造影术（ERCP）后胰腺炎是一种严重且潜在危及生命的不良事件，在疑似Oddi 括约肌功能障碍（SOD）的患者中很常见。在此，我们旨在确定该人群的风险预测因素。
患者和方法：评估 SOD 预测因素和干预措施（EPISOD）研究前瞻性纳入了美国 7 个中心的 214 例胆囊切除术后 SOD Ⅲ型患者。患者按 2:1 比例随机分配至括约肌切开术或假手术组，而不考虑 Oddi 括约肌测压结果。括约肌切开术组中胰腺括约肌压力升高的患者随机分为仅胆道切开术或双（胆道和胰腺）括约肌切开术。除 1 例患者外，所有患者均接受预防性胰管支架置入，但均未接受药物预防。ERCP 后胰腺炎（PEP）定义为随后 7 天内发生的急性胰腺炎。各研究中心的盲法研究协调员在术后 1 周致电患者。
结果：26 例患者发生 PEP，括约肌切开术组 15 例（10.6%[15/141]），假手术组 11 例（15.1%[11/73]）；未调整的相对风险 0.71（95%置信区间[95%CI]0.34-1.46）。与接受假手术治疗的患者相比，接受括约肌切开术的患者的 PEP 发生率无显著差异。此外，接受单纯胆道括约肌切开术的患者（12/94；12.8%[95%CI 6.0%-19.5%]）与接受双括约肌切开术的患者（3/47；6.4%[95%CI 0.0%-13.4%]）之间的比例也无统计学差异。多变量分析发现 ERCP 持续时间和镇静类型之间存在交互作用（P<0.02）。
结论：在疑似 SOD 的患者中，行胆道或双括约肌切开术并不会增加 PEP 的风险。然而，在这项前瞻性研究中，在专家中心中尽管使用了胰管支架，疑似 SOD 患者的 PEP 发生率仍然很高。应进一步探讨 ERCP 持续时间和镇静类型联合作用对 PEP 发展的影响。
临床试验注册：NCT00688662。
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